RT Journal Article
SR Electronic
T1 Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 418
OP 426
DO 10.1136/gutjnl-2020-320690
VO 70
IS 2
A1 Klaus Gottlieb
A1 Marco Daperno
A1 Keith Usiskin
A1 Bruce E Sands
A1 Harris Ahmad
A1 Colin W Howden
A1 William Karnes
A1 Young S Oh
A1 Irene Modesto
A1 Colleen Marano
A1 Ryan William Stidham
A1 Walter Reinisch
YR 2021
UL http://gut.bmj.com/content/70/2/418.abstract
AB Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument). In this review, academic and industry experts review scoring systems, and propose a theoretical framework for central reading that predicts when improvements in statistical power, affecting trial size and chances of success, can be expected: Multireader models can be conceptualised as statistical or non-statistical (social). Important organisational and operational factors, such as training and retraining of readers, optimal bowel preparation for colonoscopy, video quality, optimal or at least acceptable read duration times and other quality control matters, are addressed as well. The theory and practice of central reading and the conduct of endoscopy in clinical trials are interdisciplinary topics that should be of interest to many, regulators, clinical trial experts, gastroenterology societies and those in the academic community who endeavour to develop new scoring systems using traditional and machine learning approaches.